Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Brief summary
Preliminary evidence suggest that patients with chronic obstructive pulmonary disease (COPD) suffer from lower-limb muscle dysfunction. This may, at least in part, be due to a combination of physical inactivity and muscle oxidative stress. Pilot data (not published) clearly show that patients with COPD have significantly lower carnosine, which is a pH (acidity-basicity level) buffer and antioxidant, levels in the m. vastus lateralis compared to healthy subjects. Beta-alanine supplementation has shown to increase muscle carnosine in trained and untrained healthy subjects. This study will assess if muscle carnosine can be augmented by beta-alanine supplementation in 40 COPD patients (20 patients receive beta-alanine, 20 patients receive placebo). 10 healthy elderly controls will also be assessed to compare baseline muscle carnosine levels. The aims of this study are to: 1. Investigate baseline muscle carnosine levels to confirm the pilot data in a larger sample of patients with COPD compared with healthy elderly subjects 2. Investigate if beta-alanine supplementation augments muscle carnosine in COPD patients and whether it has an influence on exercise capacity, lower-limb muscle function and quality of life 3. To investigate baseline and post supplementation structural and metabolic muscle characteristics and markers of oxidative stress and inflammation in COPD patients and it's association with muscle carnosine levels
Interventions
DIETARY_SUPPLEMENTbeta-alanine
Patients receive beta-alanine
DIETARY_SUPPLEMENTplacebo
Patients receive placebo
OTHERcontrol
Healthy controls will be assessed to compare baseline muscle carnosine levels
Sponsors
Jessa Hospital
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* COPD: diagnosis of moderate to very severe COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines * Healthy controls: forced expiratory volume at one second/forced vital capacity (FEV1/FVC) \> 0.7, matched for age and gender
Exclusion criteria
* The presence of known instable cardiac disease * neurological disease and/or musculoskeletal disease that preclude safe participation in an exercise test * a history of drugs/alcohol abuse * vegetarianism * inability to understand the Flemish language. COPD-specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| muscle carnosine | change from baseline to 12 weeks | by means of high pressure liquid chromatography(HPLC)-analysis of a muscle biopsy |
| maximal exercise capacity | change from baseline to 12 weeks | by means of an incremental maximal cycle test |
| submaximal exercise capacity | change from baseline to 12 weeks | by means of a constant-work rate cycle test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory muscle function | change from baseline to 12 weeks | by means of measuring respiratory muscle strength (maximal inspiratory and expiratory pressure) |
| Muscle function hand grip | change from baseline to 12 weeks | by means of measuring hand grip strength |
| Muscle characteristics | change from baseline to 12 weeks | Structural and metabolic parameters will be measured with dedicated methodology |
| Blood parameters submaximal exercise test | change from baseline to 12 weeks | by means of obtaining venous blood before, during and after the constant-work rate cycle test. Blood parameters will be measured with dedicated methodology. |
| Blood parameters fasted state | change from baseline to 12 weeks | by means of obtaining fasting venous blood. Blood parameters will be measured with dedicated methodology. |
| Blood parameters maximal exercise test | change from baseline to 12 weeks | by means of obtaining venous blood before and after the maximal cycle test. Blood parameters will be measured with dedicated methodology. |
| Comorbidities | change from baseline to 12 weeks | by means of Charlson Morbidity index |
| Comorbidities: ankle-brachial pressure index | change from baseline to 12 weeks | by means of ankle-brachial pressure index |
| Comorbidities blood pressure | change from baseline to 12 weeks | by means of resting systolic and diastolic blood pressure |
| Comorbidities body composition 1 | change from baseline to 12 weeks | by means of bio-electrical impedance |
| Functional exercise test 1 | change from baseline to 12 weeks | by means of a 6 minutes walk test |
| Quality of life: anxiety and depression | change from baseline to 12 weeks | by means of the Hospital Anxiety and Depression Scale |
| Quality of life: fatigue | change from baseline to 12 weeks | by means of the Multidimensional Fatigue Inventory |
| Quality of life: dyspnea | change from baseline to 12 weeks | by means of the Modified Medical Research Council (MMRC) dyspnea grade |
| Quality of life: general | change from baseline to 12 weeks | by means of the Euroqol 5 dimensions (EQ-5D) generic questionnaire |
| Quality of life: COPD | change from baseline to 12 weeks | by means of the COPD assessment test |
| Physical activity: accelerometer | change from baseline to 12 weeks | by means of physical activity monitoring via Actigraph (accelerometer) |
| Physical activity: questionnaire 1 | change from baseline to 12 weeks | by means of physical activity monitoring via Behavioural Regulation in Exercise Questionnaire |
| Physical activity: questionnaire 2 | change from baseline to 12 weeks | by means of physical activity monitoring via Modified Baecke questionnaire |
| Lung function | change from baseline to 12 weeks | by means of general pulmonary function (spirometry, long volumes, diffusion capacity for carbon monoxide). |
| Heart function | change from baseline to 12 weeks | by means of resting ECG testing |
| Comorbidities body composition 2 | change from baseline to 12 weeks | by means of whole body dual X-ray absorptiometry |
| Functional exercise test 2 | change from baseline to 12 weeks | by means of a 4 meter gait test |
| Muscle function quadriceps | change from baseline to 12 weeks | by means of measuring quadriceps (isometric and isokinetic knee extension-flexion) |
Countries
Belgium
Outcome results
None listed